Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

NCT ID: NCT01363271

Last Updated: 2012-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-05-31

Brief Summary

This is a retrospective, observational, non-interventional drug study using de-identified data from two administrative claims datasets. The study design and analysis will reflect the perspective of the commercially insured. The objectives of this study are twofold:

1. To compare the rates of re-hospitalization among patients treated with either linezolid orally or IV, or vancomycin IV for complicated skin and skin structure infections (cSSSI) or pneumonia hospitalization.

2. To compare the total direct medical costs of patients treated with linezolid orally or IV, or vancomycin IV for cSSSI or pneumonia hospitalization.

Detailed Description

A sampling method is not used in this study since it is a retrospective, non-interventional claims database analysis. Pre-specified inclusion/exclusion criteria and ICD-9, NDC, HCPC codes are applied to identify the study cohorts.

Conditions

Complicated Skin and Structure Infection; Nosocomial Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

complicated skin and skin structure infections (cSSSI)

Identified through a pre-specified list of ICD-9 codes in study protocol.

Linezolid

Intervention Type: DRUG

IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).

Vancomycin

Intervention Type: DRUG

IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).

Pneumonia

Identified through a pre-specified list of ICD-9 codes in study protocol.

Linezolid

Intervention Type: DRUG

IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).

Vancomycin

Intervention Type: DRUG

IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).

Interventions

Linezolid

IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).

Intervention Type: DRUG

Vancomycin

IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).

Intervention Type: DRUG

Linezolid

IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).

Intervention Type: DRUG

Vancomycin

IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with a hospitalization for cSSSI or pneumonia for which the discharge date (i.e. index date) is between January 1, 2007 and September 30, 2009.
• Patient must have a claim for either vancomycin (IV) or linezolid (IV or oral) within 7 days following their cSSSI or pneumonia hospitalization discharge date (i.e. index date). We will exclude patients who initially receive both vancomycin and linezolid on the same day. We will apply an intention-to-treat approach and use the first drug as the index drug, even if the "comparator drug" (e.g. vancomycin for linezolid and vice-versa) is used subsequently on a future date. If there are both oral and IV formulations of the same index drug on the same index date, the patient will be kept and categorized as an IV user. As with all duplicate claims, for two claims that have both oral and IV index drug as well as the same IV and oral costs on the same index date, the claim with the oral drug will be removed, and the patient will be called an IV user.
• 18-64 years of age at index date.
• Continuous eligibility for six months prior to the index hospitalization date. No minimum of post-index continuous enrolment is required to assure that early mortality patients are included (maximum of 180 days after the index vancomycin or linezolid claim).

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:

• Patients who were enrolled in Medicare.
• Patients who were over age 65 or younger than 18.
• Patients with fewer than 3 days of oral therapy.
• Patients with index hospitalization of greater than 30 days.
• Patients with osteomyelitis, infective endocarditis, meningitis, joint infections, necrotizing fasciitis, gangrene, prosthetic joint infection, or prosthetic implant/ device infection during index hospitalization.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland

OTHER

Sponsor Role: collaborator

Lodise & Lodise, LLC

UNKNOWN

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5951160&StudyName=Cost%20Study%20of%20Linezolid%20Versus%20Vancomycin%20Among%20Previously%20Hospitalized%20Patients

To obtain contact information for a study center near you, click here.

Other Identifiers

A5951160

Identifier Type: -

Identifier Source: org_study_id